drugset / Trial / NCT01570634

Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection

NCT01570634 ↗

NaSingle-groupOpen-labelTreatment

Summary

Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to life-threatening colitis. Illness from C. difficile most commonly affects patients in hospitals and long-term care facilities and typically occurs after a patient has received antibiotics. In vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce severity of fever, leukocytosis, and bowel injury in patients with C. difficile infection. This would likely occur in conjunction with neutralization of C. difficile toxins A\&B by CASAD. Computer modeling of CASAD performed by Phillips et al. at Texas A\&M University supports this hypothesis. The investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care therapy will reduce the duration and severity of diarrhea and other symptoms in patients with C. difficile infection.

Timeline

Start
2012-03
Primary completion
2012-09
Completion
2012-09

Outcome

Outcome not reported

Stopped (Enrollment): “Study was stopped for slow enrollment - only 2 patients, no evaluable results”

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcium Aluminosilicate Anti-Diarrheal Unknown 1.5 g Oral